Evaluation of the effect of preoperative administration of pregabalin in comparison with co-administration of pregabalin and celecoxib on postoperative pain of laparoscopic cholecystectomy under general anesthesia
Determining the effect of preoperative single-dose pregabalin in comparison with celecoxib on pain relief and also reducing the average morphine use and its complications after laparoscopic cholecystectomy under general anesthesia
Design
A controlled, double-blind, randomized clinical trial on 60 patients
Settings and conduct
Place of study performance: Kashani Hospital, Shahrekord city;
Study population: acute and chronic cholecystitis patients candidate for laparoscopic cystectomy under general anesthesia;
Type of blinding: with coded sealed pockets;
Method of blinding: coding was done by one of the colleagues of the study and nurses and patients were blinded to drugs
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ultrasonographic results confirm the presence of gallstones, symptomatic gallstone disease, candidate for elective laparoscopic cholecystectomy, ASA class 1 and 2, age between 20 to 65 years, and consent to participate in the study.
Non-inclusion criteria: History of diseases affecting vital signs including heart failure, lung, confirmed malignancy, people older than 65 years, history of drug addiction, need for open cholecystectomy, people with contraindications to anesthesia or opioids
Intervention groups
Intervention Group 1: Administration of only pregabalin;
Intervention Group2: Administration of pregabalin with celecoxib;
Control group: receiving placebo.
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210309050652N1
Registration date:2023-07-23, 1402/05/01
Registration timing:retrospective
Last update:2023-07-23, 1402/05/01
Update count:0
Registration date
2023-07-23, 1402/05/01
Registrant information
Name
Ali Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3225 3752
Email address
dr.sadeghian@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-27, 1400/09/06
Expected recruitment end date
2022-01-26, 1400/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of preoperative administration of pregabalin in comparison with co-administration of pregabalin and celecoxib on postoperative pain of laparoscopic cholecystectomy under general anesthesia
Public title
The effect of pregabalin on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of ultrasonographic results confirming the presence of gallstones
Symptomatic gallstone disease
Candidate for elective surgery for laparoscopic cholecystectomy
ASA Class 1 and 2
Age between 20 and 65 years
Satisfaction to participate in the study
Exclusion criteria:
Dissatisfaction with participating in the project
History of diseases affecting vital signs including heart and lung failure
Confirmed malignancy
Need an open cholecystectomy
People older than 65 years
History of Addiction
Occurrence of unwanted complications during the operation
People with contraindications to anesthesia or opioids (patients with known hypersensitivity to the compounds of various anesthetics)
Patients with inability to answer visual pain ruler questions
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to three groups: A(control), B (only pregabalin) and C (combination of pregabalin and celecoxib), by block randomization with block size of 6. In each block, 2 patients of each group will be exist. The order of blocks will be determined randomly in A or B or C groups and subjects will be allocated sequentially in order of admission. The random allocation rule method was used for the determination of sequences using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients receive drugs (interventions or control groups) in closed pockets which are coded and patients are not aware of their contents. Coding will be done by one of the colleagues of the study and the evaluator nurse will be blind for the type of drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences; Rahbar Boulevard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SKUMS.REC.1400.179
Health conditions studied
1
Description of health condition studied
Acute Postoperative Pain
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis
Primary outcomes
1
Description
Patients' pain score based on visual and descriptive numerical pain questionnaire
Timepoint
Measurement of patients' pain, immediately after waking up in recovery, two and four hours after surgery
Method of measurement
Visual Analog Scale questionnaire
Secondary outcomes
1
Description
The need for Narcotic Analgesics after surgery
Timepoint
Immediately after waking up in recovery, two to four hours after surgery
Method of measurement
Mg Morphin
2
Description
Hemodynamic symptoms
Timepoint
Immediately after waking up in recovery, two to four hours after surgery
Method of measurement
By measuring heart rate, pulse oximetry, respiratory rate, using blood pressure device
Intervention groups
1
Description
Intervention group: Patients receiving pregabalin (capsule, 150 mg, product by Sobhan company, one time, oral, as single dose 2 hours before starting surgery) with celecoxib (capsule, 200 mg, product by Amin company, one time, oral, as single dose 2 hours before starting surgery)
Category
Prevention
2
Description
Intervention group: Patients receiving only pregabalin (capsule, 150 mg, product by Sobhan company, one time, oral, as single dose 2 hours before starting surgery)
Category
Prevention
3
Description
Control group: They receive placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital, Shahrekord
Full name of responsible person
Ali Sadeghian
Street address
Rahbar Bolvar, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4401
Email
dr.sadeghian@outlook.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Esfandyar Heydarian
Street address
Rahbar Bolvar, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4401
Email
dr.sadeghian@outlook.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hossein Madineh
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahre-kord University of Medical Sciences; Rahbar Boulevard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4401
Email
madineh@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Hossein Madineh
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahre-kord University of Medical Sciences; Rahbar Boulevard
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3232 4401
Email
madineh@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Sadeghian
Position
Anesthesiologist Physician Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashani Hospital, Kashani Blvd, Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Phone
+98 38 3225 3752
Fax
Email
a.sadeghian@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The individual data of the study participants are considered and all the data can potentially be shared after the individuals are not identified.
When the data will become available and for how long
October 2022
To whom data/document is available
Notification is allowed
Under which criteria data/document could be used
Notification is allowed
From where data/document is obtainable
Notification is allowed
What processes are involved for a request to access data/document